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Efficacy and safety of Qinpi Tongfeng Formula in the treatment of acute gouty arthritis: a randomized, double-blinded, double dummy, parallel-controlled trial

Efficacy and safety of Qinpi Tongfeng Formula in the treatment of acute gouty arthritis: a randomized, double-blinded, double dummy, parallel-controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050638
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-09-15
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute gouty arthritis

Interventions

Experimental group:Qinpi Tongfeng Formula granule, one bag Tid+Simulant of phenanthrene sodium dichlorate sustained release tablets 0.1g Qd
Control group:Simulant of Qinpi Tongfeng Formula granule, one bag Tid+ phenanthrene sodium dichlorate sustained release tablets 0.1g Qd

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for acute gouty arthritis; 2. Meet the diagnostic criteria of damp heat accumulation syndrome of gout in traditional Chinese medicine; 3. The patient's disease is within 72 hours of the onset of acute gouty arthritis; 4. The patient has had gout at least once; 5. The patient also needs to have moderate, severe or extreme joint pain, and the pain VAS score is >= 4; 6. Those who did not take other drugs for gouty arthritis within 72 hours before enrollment; 7. Those who have not taken uric acid lowering drugs in recent 2 weeks; 8. Aged 18 to 70 years; 9. The subjects agreed to join the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Secondary gouty arthritis caused by renal failure, tumor chemotherapy or radiotherapy, drugs, etc; 2. Patients with chronic gout; 3. Patients with inflammatory arthritis diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and knee osteoarthritis; 4. The patient has multi joint gout (> 4 joints); 5. Patients with serious primary diseases such as cardiovascular, cerebrovascular, lung, kidney, endocrine and hematopoietic system; 6. Alt, AST or Cr are greater than 1.5 times ULN (upper limit of normal value); 7. Those who are allergic to the test drug components; 8. Patients with asthma, urticaria or allergic reaction induced by aspirin or other non steroidal anti-inflammatory drugs; 9. Pregnant, pregnant or lactating women; 10. Patients with active peptic ulcer or bleeding, or who have suffered from peptic ulcer or bleeding in the past; 11. Those who have participated or are participating in other clinical trials in recent 1 month; 12. Mental illness, lack of insight, unable to express accurately or take medicine on time, and unable to cooperate to complete the test.

Design outcomes

Primary

MeasureTime frame
Pain score;

Secondary

MeasureTime frame
Total effective rate;Complete pain relief time;Joint symptom score;Traditional Chinese Medicine syndrome score;Patient satisfaction score;C-reactive protein;erythrocyte sedimentation rate;blood uric acid;

Countries

China

Contacts

Public ContactLiu Wei

First Teaching Hospital of Tianjin University of TCM

fengshiliuwei@163.com+86 13516161000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026